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Sunday, February 23, 2014 1:46:55 PM
...interesting how many of these warnings "may" take place during cancer treatment that requires a doctor to pull the plug on that given treatment --- but many times with the added pain medication and overall state of mind of cancer patients ( many of us have first hand knowledge of this with self, family, friends..etc) -- and the pulling the plug is just not a viable option as "time" is of the essence with any cancer treatment.
Bavituximab is right around the corner... and what did the Romans say, "The Ides of March" ... approaching fast
https://rm2.scinet.fda.gov/druglabel/#simsearch-2
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example... Yervoy warning from the FDA website, though you need to go to the link and read "all" the warnings as below gives just an overview.
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
See full prescribing information for complete boxed warning.
YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. (2.2)
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. (5.1, 5.2, 5.3, 5.4, 5.5)
http://https://rm2.scinet.fda.gov/druglabel/rs/spl/by-id/95627/95627.html
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!
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